Device for collection of cells from the vagina

ABSTRACT

A device of unitary structure for collecting and withdrawing exfoliated cells from the vagina for the purpose of enabling Papanicalaou testing, venereal disease testing the like. The device is formed as a tubular structure having one end rounded for insertion and including a plurality of axially aligned ridges disposed alternately with plural rows of diagonal slots, the slots of each row having a different capillary action capability; the tubular structure is further characterized to include axially aligned slots and an axial end hole at the insertion end to provide optimum functional, yet non-irritating, contact with the cervix and cervical area of the vagina.

United States Patent [191 Dalton 1 1 Oct. 1, 1974 [5 DEVICE FOR COLLECTION OF CELLS 3,450,129 6/1969 Avery et al. 128/2 w FROM THE VAGINA 3,540,432 11/1970 Ayre 128/2 B 3,633,565 1 1972 McDonald 128/2 B [76] Inventor: John J. Dalton, 6808 S. Country Club Dr., Oklahoma City, Okla.

[22] Filed: Dec. 29, 1972 [21] Appl. No.: 319,288

[52] US. Cl. 128/2 B, 128/2 W, 128/304 [51] Int. Cl A61b 10/00 [58] Field 01 Search 128/2 B, 2 W, 2 R, 304, 128/239 [56] References Cited UNITED STATES PATENTS 1,064,307 6/1913 Fleming 128/239 1,638,532 8/1927 Kallmeyer.. 128/239 2,047,437 7/1936 Sinkler 128/239 X 2,484,290 10/1949 Handel.... 128/239 2,701,559 2/1955 Cooper 128/2 B 3,225,763 12/1965 Waterman 128/239 X Primary Examinerl(yle L. Howell 5 7 ABSTRACT A device of unitary structure for collecting and withdrawing exfoliated cells from the vagina for the purpose of enabling Papanicalaou testing, venereal disease testing the like. The device is formed as a tubular structure having one end rounded for insertion and including a plurality of axially aligned ridges disposed alternately with plural rows of diagonal slots, the slots of each row having a different capillary action capability; the tubular structure is further characterized to include axially aligned slots and an axial end hole at the insertion end to provide optimum functional, yet nonirritating, contact with the cervix and cervical area of the vagina.

5 Claims, 11 Drawing Figures PATENIEBUCT H974 sum 2 or an,

DEVICE FOR COLLECTION OF CELLS FROM THE VAGINA BACKGROUND OF THE INVENTION lates to an improved device for collection of requisite '0 cell matter from the human female for the purpose of cancer, gonnococcal and other venereal testing and the like.

2. Description of the Prior Art The prior art now includes several similar types of cell collection device which are primarily directed to usage by the female user herself incollecting uterine and cervical exfoliated cells from the membranes of the vaginal walls and vaginal pool. Each of the known prior devices has been used only in association with a specified liquid which is expelled or somehow placed within the vagina prior to extraction of the device with disposition of collected cells. The use of such liquids have exhibited an inherent shortcoming due to the fact that each causes some form of discomfort and/or irritation to the vaginal membranes as well as the possibility of unknown long term effects which could arise after prolonged usage.

SUMMARY OF THE INVENTION The present invention contemplates a cell collection device wherein a female user, in her own privacy and at her own leisure, can collect the requisite vaginal cell matter for use in cancer and venereal disease testing, e.g., the Papanicalaou or well-known Pap test. In a more limited aspect, the cell collection device consists of a tubular structure having a rounded end providing smooth, easy vaginal insertion. The portion of the tubular structure to be inserted is further characterized by a plurality of axial ridges and a plurality of diagonal grooves having different capillary action capability, which in combination provide a high degree of exfoliated cell collection when the inserted collection device is rotated. Further ridge and slot structure as well as an axial end aperture are provided about the rounded insertion end of the collection device thereby to provide optimum contact with the cervix and surrounding area.

Therefore, it is an object of the present invention to provide a self-administered vaginal cell collection device having a high degree of efficiency for its intended usage.

It is also an object of the present invention to provide a cell collection device which will maintain an optimum efficiency despite variations as to the physical characteristics and viscosity of membrane fluids and the like of the individual user.-

Finally, it is an object of the present invention to provide an exfoliated cell collection device for insertion in the vagina which uses no liquid or other material in association therewith. I

Other objects and advantages of the invention will be evident from the following detailed description when read in conjunction with the accompanying drawings which illustrate the invention.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. I is a perspective view of the present invention;

FIGS. 2A. 2B, 2C and 2D are partial elevations ofthe insertion end of the invention as progressively rotated by FIG. 3 is a plan view of the collection deviceas it is mold constructed;

FIG. 4 is a vertical section taken through the collection device as shown in FIG. 3;

FIG. 5 is a vertical section of the collection device as illustrated in FIG. 4 when the device is closed and in operative form;

FIG. 6 is a plan view of an alternative form of cell collection device as constructed in accordance with the present invention;

FIG. 7 is a plan view of the device of FIG. 6 rotated by 90; and

FIG. 8 is a section taken along line 8-8 of FIG. 7.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT As shown in FIG. 1, a cell collection device 10 is formed as an elongated, tubular structure 12 having an insertion portion 14 with a rounded insertion end 16, and a manipulating end 18. The manipulating end 18 is formed to include a plurality of axially aligned ridges 20 peripherally disposed thereabout and providing more firm finger gripping of device 10 when in use.

The insertion portion 14 of device 10 includes a quadrature array of alternating ridges and slots; thus, axial ridges 22, 24, 26 and 28 (see also FIGS. 2A-D) are formed along the manipulating section 14 in 90 displaced relationship. and a plurality of diagonally transverse and parallel slots are formed between each successive pair of ridges 22, 24, 26 and 28. A parallel group of slots 30 is formed by a plurality of slots 32 and, in like manner, a plurality of slots 34 are formed by slots 36, a plurality of slots 38 formed by slots 40, and a plurality of slots 42 as formed by slots 44 (see opposite side view, FIG. 2C).

Each of the diagonal slots 32, 36, 40 and 44 are disposed at a diagonal angle to the transverse which provides an optimum scraping and collecting efficiency, e.g., on the order of 45 to the transverse; and, each of slots 32, 36, 38 and 40 are formed to be of slightly different width thereby to provide most favorable capillary attraction of membrane liquids and materials in suspension for all possible users as it is known that the native fluid materials of the female vagina will vary over specific ranges as to viscosity, density, electrolytic substance, etc. Thus, for example, the slots 32 of group 30 may be formed to have a width of 0.030 inches, slots 36 with a width of 0.034 inches, slots 40 with a width of 0.038 inches and slots 44 with a width of 0.042 inches.

The insertion end 16 of device 10 is formed as a smooth rounded configuration having an axial aperture 46 formed therein as well as a quadrature array of axial slots 48, 50, 52 and 54. The axial slots are each formed on the rounded portion of insertion end 16, and these, too, may be formed of respective different widths similar to the diagonal slots 32-44 in the like quadrants of tubular structure 12.

Considerable problems of manufacture and expense are solved ,by forming the device 10 as a one-piece mold structure, as shown in FIG. 3. The device 10 is singularly molded as two semi-cylindrical side portions 60 and 62 as joined along one edge by a thin hinge panel 64. As shown also in FIG. 4, the outer edge of tube portion 60 is formed to include an axially extending groove 66, and the outer edge of tube portion 62 is formed to include an axially extending interlocking land 68. Thus, and referring to FIG. 5, it is only necessary to bend the molded article along the hinge 64 to close interlocking land 68 within groove 66 along the length of collecting device 10 such that the tubular structure 12 is permanently formed, and the collecting device 10 is ready for usage. It can be noted, too, from FIGS. 4 and 5 that after folding enclosure to form tubular structure 12, the hinge panel 64 takes a ridge form to provide the axial ridge 22.

In operation, it is proposed that the cell collecting device be supplied to the user along with a sealable tube containing a suitable carrier or vehicle solution, saline solution or the like, such that the female user can insert and manipulate the collecting device 10 in prescribed manner and then merely insert the collecting device 10 within the well-sealed tube with subsequent shaking of the tube to assure contact of all collected cell matter in the vehicle solution.

In prescribed usage, the female user need only grasp the manipulating end 18 of collection device 10 for manual insertion upward into the vagina. It is assumed that the user will assume a most comfortable position suitable for her particular insertion as this will vary greatly with different female users. The collecting device 10 is then inserted as far as possible, i.e.. until firm resistance is met, to assure that the insertion end [6, axial aperture 46 and end slots 48, 50, 52 and 54 will come into contact with the cervix and cervical area. Upon positioning, it is recommended that the user merely rotate collecting device 10 by three or four revolutions, withdraw the collecting device 10, and thereafter place collecting device 10 in the provided sealable tube of vehicle liquid. It is then merely necessary to deliver the tube and material to a qualified laboratory, gynecologist or other qualified cytotechnologist.

The above-described insertion and rotation procedure has several favorable effects. Since the vaginal tract in most female users is a curved or up-tilted passageway, the insertion of a rigid collecting device 10 causes a straightening out of the tract to provide firm pressures more deeply up within the vaginal tract in the area of the cervix. Thereafter, with rotation of collecting device 10, the coactive effects of capillary attractive scraping slots 32-44 and the scraping ridges 22-28 effect optimal collection of exfoliated cell matter present in the vaginal upper tract. In addition, rotation of the axial aperture 46 and end slots 48-54 provide effective yet non-irritating contact with the cervix and its surrounding area thereby to effect collection of a greater amount of more freshly deposited exfoliated cell matter. It should also be noted that use of cell collection device 10 relies in no way upon collection of matter from the vaginal pool as is requisite in other prior art selfadministered devices.

FIGS. 6, 7 and 8 illustrate an alternative form of cell collecting device 70 which is also of rigid nature and may be molded from selected plastic materials. The collecting device 70 is formed to include a suitable handle 72 with a gripping end portion 74, handle 72 being formed integral with and extending into a hollow, cylindrical collecting portion 76. The collection portion 76 includes a single axially aligned scraping ridge 78 integrally formed along the side thereof (see also the end view of FIG. 8), and there is formed therein a plurality of axially linearlyarrayed indentations 80. Still further. one side of collection portion 76 is extended as an arcuate projection 82 to provide more efiicient scraping of the cervix and cervical area.

The indentations 80 as arrayed along the outer surface of scraping portion 76 and arcuate projection 82 may be varied as to outside diameter to aid in capillary attraction of collected matter. The arcuate projection 82 also includes a plurality of end indentations 84, and a plurality of axially aligned scraping ridges 86 and indentations 88 as formed on the inner surface of arcuate projection 82. A pair of transverse grooves 90 and 92 are formed about approximately one-quarter of a conical joinder formation 94 between handle 72 and collecting portion 76.

In operation, the collecting device is used in the same manner as is the collecting device 10 of FIG. I. That is, the device is manually inserted by means of handle 72 to extend collecting portion 76 inward and upward within the vagina until arcuate projection 82 comes in contact with the cervical area. whereupon,

rotation of device 70 by means of gripping end 74 serves to move the arcuate projection 82 about the cervix in pressing but non-irritating contact, and exfoliated cells are collected by the combination of indentations and scraping ridges 78 and 86. Further, upon removal of the collecting device 70, the transverse grooves and 92 serve to collect still further cell matter from yet another area of the vaginal tract. The removed collecting device 70 is then placed in a selected form of sealable tube containing the vehicle liquid, shaken, and then delivered or dispatched to a doctor or processing facility.

It is presently contemplated that the selfadministered cell collection devices can be made readily available through available merchandising outlets suchas supermarkets, drug stores, federal facilities and the like, thus enabling a far greater percentage of females to have the advantage of the Papanicalaou test, venereal disease test, etc. In particular, this would be a great stride forward in detection andprevention of uterine and cervical cancer, as a very large percentage of females do not yet avail themselves of the test possi bilities due to the fact that they do not bother, are embarrassed by gynecological proceedings, or are uninformed through not having adequate medical advice and contact with knowledgeable physicians. The present invention enables a fool-proof device which anyone can use and thereby obtain good results. It has already been proven in clinical testing that the collecting devices described herein will provide a greater crosssection of cell types and much greater volume of total cell collection than any of the prior art devices including the traditional scraping and sampling tools of the gynecologist.

Changes may be made in the combination and arrangement of elements as heretofore set forth in the specification and shown in the drawings; it being understood that changes may be made in the embodiments disclosed without departing from the spirit and scope of the invention as defined in the following claims.

characterized to include:

a plurality of gripping formations formed on the external surface of said manipulating end. 3. A device as set forth in claim 1 which is further What is claimed is:

l. A device for collecting exfoliated cells from the vagina of a subject user, comprising:

a unitary structure formed as a hollow, cylindrical tubing having a manipulating end and an insertion end which is closed in rounded form to define an axial aperture therein, said cylindrical structure being entirely rigid and including a plurality of scraping ridges formed axially in circularly spaced relationship on the external surface thereof, and said tubular structure further including plural rows of parallel slots aligned transversely diagonally with each row disposed between adjacent ones of said scraping ridges, said slots of each of said plural rows being formed to have a different width within a range of widths assuring varying degrees of capillary attractive action relative to liquids encountered.

2. A device as set forth in claim 1 which is further 5 characterized to include:

a plurality of axially aligned slots disposed equispaced around the rounded insertion end adjacent said axial aperture.

4. A device as set forth in claim 3 wherein each of 0 said axially aligned slots has a different width.

5. A device as set forth in claim 1 which is further characterized in that:

said unitary structure comprises two generally semicylindrical halves joined along one adjacent side by a hinge panel with the opposite sides including fastener structure such that the semicylindrical halves may be closed and fastened to form said cylindrical tubing. 

1. A device for collecting exfoliated cells from the vagina of a subject user, comprising: a unitary structure formed as a hollow, cylindrical tubing having a manipulating end and an insertion end which is closed in rounded form to define an axial aperture therein, said cylindrical structure being entirely rigid and including a plurality of scraping ridges formed axially in circularly spaced relationship on the external surface thereof, and said tubular structure further including plural rows of parallel slots aligned transversely diagonally with each row disposed between adjacent ones of said scraping ridges, said slots of each of said plural rows being formed to have a different width within a range of widths assuring varying degrees of capillary attractive action relative to liquids encountered.
 2. A device as set forth in claim 1 which is further characterized to include: a plurality of gripping formations formed on the external surface of said manipulating end.
 3. A device as set forth in claim 1 which is further characterized to include: a plurality of axially aligned slots disposed equi-spaced around the rounded insertion end adjacent said axial aperture.
 4. A device as set forth in claim 3 wherein each of said axially aligned slots has a different width.
 5. A device as set forth in claim 1 which is further characterized in that: said unitary structure comprises two generally semi-cylindrical halves joiNed along one adjacent side by a hinge panel with the opposite sides including fastener structure such that the semi-cylindrical halves may be closed and fastened to form said cylindrical tubing. 